Psychological and Lifestyle Factors on Health Outcomes
NCT04780867 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1188
Last updated 2023-10-05
Summary
Psychosocial and lifestyle factors in Army recruits likely contribute to increased susceptibility to infection and injury during basic Army training. The primary aim of this study is to assess the influence of psychosocial and lifestyle factors at the start of basic Army training on immune health (e.g. respiratory infection and antibody response to influenza vaccination) and injury during training, in an observational design.
A secondary aim is to establish whether changes in psychosocial and lifestyle factors during training impact immune health (e.g. response to hepatitis B vaccination). Using an interventional design, participants will be randomly allocated into two experimental groups: (i) Routine vaccination group: to receive first hepatitis B vaccination at initial medical assessment upon entry to basic training and second hepatitis B vaccination 1 month later; (ii) Delayed vaccination group: to receive first hepatitis B vaccination during week 5 of training and second hepatitis B vaccination 1 month later.
Conditions
- Psychological
- Stress
- Immune Health
- Vaccination
- Respiratory Tract Infections
- Injury
Interventions
- BEHAVIORAL
-
Delayed vaccination
First and second hepatitis B vaccinations will be delayed by 1 month in the interventional group to establish whether changes in psychosocial and lifestyle factors during training impact immune health.
Sponsors & Collaborators
-
University of Nottingham
collaborator OTHER -
University of California, Los Angeles
collaborator OTHER -
Loughborough University
collaborator OTHER -
Ministry of Defence, United Kingdom
collaborator OTHER_GOV -
Liverpool John Moores University
lead OTHER
Principal Investigators
-
Neil P Walsh, PHD · Liverpool John Moores University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- BASIC_SCIENCE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 16 Years
- Max Age
- 33 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2020-10-19
- Primary Completion
- 2023-01-31
- Completion
- 2023-01-31
Countries
- United Kingdom
Study Locations
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